{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T16:22:30Z","timestamp":1787502150325,"version":"build-2736575974"},"reference-count":21,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T00:00:00Z","timestamp":1777507200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T00:00:00Z","timestamp":1777507200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Erdafitinib, an oral pan\u2010\n                    <jats:italic>FGFR<\/jats:italic>\n                    inhibitor is extensively metabolized in the liver. This open\u2010label, single\u2010dose, phase 1 study evaluated the pharmacokinetics (PK) of erdafitinib in participants with hepatic impairment versus healthy controls. Overall, 26 participants were enrolled. Following a single 6\u00a0mg oral dose, the maximum plasma concentration (C\n                    <jats:sub>max<\/jats:sub>\n                    ) of total erdafitinib was reached at median t\n                    <jats:sub>max<\/jats:sub>\n                    of 3\u00a0h across all groups (participants with mild hepatic impairment, moderate hepatic impairment, and control). The geometric mean ratios for free C\n                    <jats:sub>max<\/jats:sub>\n                    and free AUC\n                    <jats:sub>\u221e<\/jats:sub>\n                    , were 96.07% and 95.22% in participants with mild hepatic impairment compared with controls, respectively. The geometric mean ratios for free C\n                    <jats:sub>max<\/jats:sub>\n                    and free AUC\n                    <jats:sub>\u221e<\/jats:sub>\n                    , were 104.8% and 87.51% in participants with moderate hepatic impairment compared with controls, respectively. Single oral doses of erdafitinib were well tolerated across all cohorts, and no new safety signals were noted. The results demonstrate that dose adjustments are not necessary in participants with mild or moderate hepatic impairment receiving oral erdafitinib.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70061","type":"journal-article","created":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T08:01:56Z","timestamp":1777536116000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Phase 1, Open\u2010Label, Single\u2010Dose Study of the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib, an\n                    <i>FGFR<\/i>\n                    Inhibitor"],"prefix":"10.1002","volume":"15","author":[{"given":"Wei","family":"Zhu","sequence":"first","affiliation":[{"name":"Clinical Pharmacology &amp; Pharmacometrics, Johnson &amp; Johnson  Raritan NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Hellemans","sequence":"additional","affiliation":[{"name":"Oncology Research &amp; Development, Johnson &amp; Johnson  Beerse Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Mitselos","sequence":"additional","affiliation":[{"name":"Oncology Research &amp; Development, Johnson &amp; Johnson  Beerse Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"De Meulder","sequence":"additional","affiliation":[{"name":"Bioanalytical Discovery &amp; Development Sciences, Johnson &amp; Johnson  Beerse Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juhui James","family":"Jiao","sequence":"additional","affiliation":[{"name":"Statistics and Decision Science, Johnson &amp; Johnson  Raritan NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui","family":"Tian","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology &amp; Pharmacometrics, Johnson &amp; Johnson  Spring House PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,4,30]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdt419"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.semcdb.2015.10.012"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-14-2329"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-14-3212"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2020.38.15_suppl.3620"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2308849"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1817323"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2023.10.003"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(21)00660-4"},{"key":"e_1_2_10_11_1","unstructured":"US Food and Drug Administration.FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma. Published January 19 2024. Accessed May 2025.https:\/\/www.fda.gov\/drugs\/resources\u2010information\u2010approved\u2010drugs\/fda\u2010approves\u2010erdafitinib\u2010locally\u2010advanced\u2010or\u2010metastatic\u2010urothelial\u2010carcinoma."},{"key":"e_1_2_10_12_1","unstructured":"Johnson & Johnson.European Commission approves BALVERSA\u00ae (erdafitinib) for adult patients with unresectable or metastatic urothelial carcinoma. Published July 2023. Accessed May 2025.https:\/\/www.jnj.com\/media\u2010center\/press\u2010releases\/european\u2010commission\u2010approves\u2010balversa\u2010erdafitinib\u2010for\u2010adult\u2010patients\u2010with\u2010unresectable\u2010or\u2010metastatic\u2010urothelial\u2010carcinoma."},{"key":"e_1_2_10_13_1","unstructured":"Janssen Pharmaceuticals Inc.Erdafitinib Prescribing Information. Published 2024. Accessed July 27 2024.https:\/\/www.janssenlabels.com\/package\u2010insert\/product\u2010monograph\/prescribing\u2010information\/ERDAFITINIB\u2010pi.pdf."},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/psp4.12727"},{"key":"e_1_2_10_15_1","unstructured":"European Medicines Agency.Erdafitinib\u2010summary of product characteristics. Published 2024. Accessed October 2024.https:\/\/www.ema.europa.eu\/en\/documents\/product\u2010information\/balversa\u2010epar\u2010product\u2010information_en.pdf."},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1547"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdw373.17"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1080\/00498254.2020.1821123"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.1412"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13318-019-00581-9"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.14954"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13585"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70061","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.70061","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70061","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T15:27:25Z","timestamp":1787498845000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.70061"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4,30]]},"references-count":21,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,5]]}},"alternative-id":["10.1002\/cpdd.70061"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.70061","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4,30]]},"assertion":[{"value":"2025-10-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-04-07","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-04-30","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70061"}}